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The Massachusetts pharmacy at the heart of a probe into a deadly meningitis outbreak may have violated federal health laws, U.S. Food and Drug Administration investigators said Friday, saying mold and bacteria were found in areas where drugs were mixed.
Cases of fungal meningitis have reached 28 states, including Maryland, where 19 people have been sickened and one has died. The report came as Maryland health officials criticized the oversight of "compounding" facilities like the one in Massachusetts, which make specialized drugs.
"We don't want this to be another chapter in a book on compounding problems," said Maryland Health Secretary Joshua M. Sharfstein, who co-wrote an online article Friday in the Journal of the American Medical Association. "We want this to be the last chapter because it leads to a solution."
The FDA said it had uncovered 83 vials from the New England Compounding Center that contained the steroid linked to the outbreak; they contained a "greenish black foreign matter." Seventeen other vials of the drug, methylprednisolone acetate, contained a threadlike white matter.
The findings were outlined Friday by the FDA in a report investigators issue when they find evidence that federal health laws may have been violated. The investigators also found potential contamination in other areas of the center where drugs weren't directly handled.
Three lots of steroids from the company are linked to the meningitis outbreak that has killed 25 people and sickened 338.
The FDA declined to provide any broad analysis or conclusions from the findings because the investigation is not complete. The report does not have legal force and the investigation needs to be completed before a decision on any action against New England Compounding Center is made, said FDA official Paul Teitell.
New England Compounding Center officials said they are reviewing the FDA report.
"We will review this report and will continue our cooperation with the FDA," the company said in statement. "We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report."
The steroid implicated in the outbreak was used to ease back pain. About 1,500 people in Maryland are among the 13,000 nationwide possibly exposed to meningitis, an infection of the membranes that protect the brain and spinal cord.
FDA investigators said they found greenish-yellow discolorations and tarnished discoloration on sterilization devices at New England Compounding Center. The pharmacy also used nonsterile pharmaceutical ingredients to make drugs even though it said the raw materials it used were sterile, the report said.
New England Compounding Center's monitoring also found contamination from January though September, including visible mold, according to the report.
The FDA report points out that a recycling facility that abuts the pharmacy handles mattresses and plastics, and contains large equipment that produces airborne particles. Rooftop air-conditioning units serving the pharmacy are about 100 feet from the recycling facility, the report said. FDA officials declined to say whether that could have been a source of the contamination.
The agency's findings are similar to those from an investigation by the state of Massachusetts, which said the facility released drugs before determining whether they were sterile, issued drugs without a prescription and, in general, did not follow proper sterilization guidelines.
As more evidence of widespread contamination at New England Compounding Center has grown, the FDA has told medical facilities nationwide to discard any drugs sold by the facility after May 21, including those unrelated to the meningitis outbreak. Earlier this week, the agency listed more than 3,000 medical facilities that brought products from the company, including 89 in Maryland.
But Maryland health officials said most of the risk comes from the three lots of steroids.
The problems at New England Compounding Center have raised questions about the regulation of compounding pharmacies, which make specialized drugs that cannot be found or are in short supply commercially. Many are small operations, but some have grown into large manufacturers.
Compounding facilities are regulated by state boards, but many are questioning whether the FDA should regulate the pharmacies because they behave more like large drug manufacturers.
The critical article written by Sharfstein and two other officials points out that the compounding pharmacy industry boasts about technology paving the way for more pharmacies to customize medications.
"The debacle at the New England Compounding Center, however, indicates that compounding has yet to fully emerge from the Dark Ages," the article reads. "All compounding pharmacies must take responsibility for the quality of what they produce."
State epidemiologist Dr. David Blythe and Dr. Lucy Wilson, chief of Maryland's infection prevention and outbreak response program, helped write the article, which ran first in the online edition of the journal.
In a phone interview, Sharfstein said ideally the FDA would set regulations for these pharmacies and the states would play a supportive enforcement role.
"States have a very important role to play," he said, "but we think there should be a clear national framework for compounding."
The Morning Sun
Those in the compounding industry have said most facilities are responsible and have standards in place to prevent the contamination of drugs.
Compounding pharmacies serve an important role in providing drugs that are needed but aren't readily available, said David Ball, a spokesman for the International Academy of Compounding Pharmacists.
Ball said compounding pharmacies provide oncology medications for cancer patients who have no other options, because the drugs they need are not commercially available. Other times, the facilities make an allergen-free form of a drug for a patient who cannot take a commercially manufactured drug because it may cause an adverse reaction, he said.
"It is important for the public to know that what is alleged to have happened at NECC is dramatically different than what happens in compounding pharmacies across the U.S. every day," Ball said. "These patients have nowhere else to turn."
He added: "Any steps that can be taken to keep patients safe can and must be taken. Any disruption to patient care, though, is not an acceptable result."
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